Quality

Check out the Kymanox brochure on Quality and Regulatory Compliance.

Quality by Design

Kymanox's overall approach to providing services is aligned with the principles of Quality by Design (QbD).  QbD is a universal quality system that incorporates sound science, knowledge transfer, risk management, Process Analytical Technology (PAT), Six-Sigma, LEAN, and other valid technical and quality tools that have been adopted by the Biotechnology, Pharmaceutical, and Medical Device industries.  When fully embraced, QbD returns higher product quality while saving time, money, and regulatory scrutiny.  Unlike other quality-based initiatives of the past, the FDA has worked diligently with other governing bodies around the globe to promote QbD as being the new standard to which regulated healthcare products will be evaluated.

Whole Enterprise Quality

With access to world-class expertise in every aspect of GMP, Kymanox can help design your internal processes so that they all work together supporting product quality.   Every system – documentation control, materials management, QC, validation, etc. – should be part of the overall solution, not part of the problem.